Gardasil® 2-dose schedule approved in the European Union for children aged from 9 to 13 years

Gardasil® 2-dose schedule approved in the European Union for children aged from 9 to 13 years

Alternative regimen for quadrivalent HPV vaccine now available for 9-13 year olds

April 3, 2014

Sanofi Pasteur MSD announced today that the European Commission has granted marketing authorisation for a 2-dose schedule at 0 and 6 months in children aged from 9 to 13 years for its quadrivalent Human Papillomavirus (HPV) vaccine. Gardasil® is the only quadrivalent HPV vaccine and is indicated in adolescent girls and boys to help protect against cervical cancer, vulvar and vaginal precancers as well as genital warts.

“We are delighted to offer this alternative 2-dose schedule which could help to extend HPV vaccine coverage and increase uptake. It is based on data showing that 2 doses elicited an immune response in adolescents, comparable to that of 3 doses in young women, to the four HPV types – 6, 11, 16 and 18 – included in Gardasil®”, said Dr Fiona Thomas, UK Medical Director for Sanofi Pasteur MSD.

The approval of a Gardasil® vaccine 2-dose schedule follows the positive opinion from the European Medicines Agency (EMA) granted in February, based on a Canadian study performed by Dobson et al. It demonstrated that the 2-dose 0, 6 month schedule in 9-13 year-old girls elicited an immune response comparable/non-inferior to that of 3 doses in the 16-26 year-old women, the population where quadrivalent vaccine efficacy has been shown. These results were sustained at 36 months of follow-up.

Adolescents aged 14 years and above should still receive 3 doses at 0, 2 and 6 months. The UK national HPV immunisation programme continues to use a 3 dose schedule for girls aged 12-13 years.1

Any change to the schedule used in the national HPV immunisation programme would have to be announced by Public Health England, following advice from the Joint Committee on Vaccination and Immunisation (JCVI).

To date, more than 29 million doses of Gardasil® have been distributed in Western Europe, helping to protect the future health of millions of adolescents.